There are several types of lesions of mucosal, submucosal, epidermal, dermal and subcutaneous tissue and various other inflammatory processes for which no effective cure has previously been found. These include aphthous ulcers, lesions of the pharynx, stomatitis, gingivo-stomatitis, cheilosis, and other types of oral lesions or inflammations of the mucosal, submucosal, dermal, epidermal, or subcutaneous tissue. The present invention has particular utility in the treatment of aphthous ulcers and other oral lesions and will be described in connection with such utility, although utility for the treatment of other types of lesions and inflammations is also indicated.
The aphthous ulcer, which is commonly referred to as a canker sore, is a painful oral lesion occuring on the mucous membranes of the tongue, lips, cheek, soft and hard palates, gingiva, floor of the mouth, or pharynx. Several factors have been suggested as possible causes of the disease known as aphthous stomatitis, which is manifested by the formation of aphthous ulcers. However, the disease is still not completely understood, and the factors which cause aphthous stomatitis are still being investigated.
One popular theory is that aphthous stomatitis is caused by stress, whether chemical, physical or emotional. Chemical stress would include consumption of spicy or highly acidic foods which alter the mucosal chemistry. Physical stress would include abrasion or irritation of the mucosal tissue by ill-fitting dentures, orthodontic appliances, or stray toothbrush bristles, as well as other types of physical trauma to the mucosal tissue which may develop into canker sores. Emotional stress resulting from an intense emotional experience, change of environment, or pressures of job, school, or personal relationships have also been associated with the formation of aphthous ulcers.
Hypersensitivity to certain foods has been postulated as a factor which may account for some cases of aphthous ulcers, but there is little evidence to support this suggestion. It is also believed that some aphthous ulcers may be virally induced. The disease has also been linked to hormonal cycles in females, who tend to suffer more frequently from the disease than males. It has been found that women who suffer chronically from the disease are free of lesions during pregnancy. It is also common for cancer patients undergoing chemotherapy to suffer from severe and persistent aphthous ulcers, which may appear in large numbers.
Even though the foregoing and other factors have been suggested as contributory to the disease, aphthous stomatitis is found in children and adults, males and females, patients with or without gastrointestinal problems, and patients with good or poor general health. There is some evidence of patterns in families of patients who are prone to developing aphthous ulcers which suggests that heredity may play a role in whether or not a patient may be susceptible to the disease. Although the foregoing as well as other factors have been examined, no definitive explanation of the mechanism of the formation of aphthous ulcers has been determined.
The ulcers typically last from 5 to 21 days. Often the ulcers form in groups and merge into a singular extensively ulcerated area. The lesions may become extremely painful, especially during periods of fatigue or during eating, which may become difficult if not impossible.
The treatment of aphthous ulcers, and lesions of the mouth in general, has heretofore only involved protecting, anesthetizing, and/or soothing the affected area as needed to ease patient discomfort until healing of the lesion is complete. The most common treatments have included the use of local anesthetics, astringents, antiseptics, protective preparations, and topical steroids. These treatments only serve to treat the problem symptomatically, temporarily relieving or reducing pain, cooling the area of the lesion, protecting the ulcer against further irritation, or reducing inflammation. Another treatment, described in U.S. Pat. No. 4,191,750 uses primarily potassium nitrate in a glycerol base as a topical preparation and reports some success with reduction of pain and promotion of healing. Potassium nitrate is an antiseptic and astringent agent which shows some benefit in the promotion of healing, but its primary benefit as applied to canker sores appears to be as an anesthetic. That preparation appears to have a relatively prolonged desensitizing effect, but it has the disadvantage of causing stinging during application before it takes effect as an anesthetic. There has been no effective method or preparation which provides a cure for aphthous ulcers.
It is therefore an object of the present invention to provide an effective treatment for aphthous ulcers which actually resolves the area of ulceration.
It is a further object of the present invention to provide a new method of preparing an effective topical treatment for aphthous ulcers.
Another object of the present invention is to provide an effective topical treatment for lesions of the mucosal tissue, including tissues of the mouth, tongue, and pharynx.
A still further object of the present invention is to provide an effective topical treatment for lesions resulting from stomatitis, gingivo-stomatitis, or cheilosis.
A still further object of the present invention is to provide an effective topical treatment for various oral lesions of the mucosal, submucosal, dermal, epidermal, and subcutaneous tissues.
Yet another object of the present invention is to provide new methods of preparing topical treatments for various oral lesions of the mucosal, submucosal, dermal, epidermal, and subcutaneous tissues.
Other objects, features and advantages will become apparent from the following description of the invention.